Why is MDR, the European Union legislation that will replace the previous Medical Manufacturers Directive 93/42 / EEC, important to us, and what changes will it bring?
It provides a much more comprehensive and detailed after-sales monitoring and product tracking system, complemented by the introduction of a unique asset identification system.
There are much stricter and detailed rules for developing and licensing of traumatological-orthopedic and spinal surgical implants: in practice, this means that the development of almost any new product requires a clinical trial.
A central implant register will be launched, which will eventually be accessible to patients to check, for example, which medical implant has a CE mark.
The Implant Card, which will be given to some patients with implants after surgery, will be introduced.
As the main goal of the new regulation is to increase patient safety, we at Sanatmetal have been preparing for the transition with great enthusiasm for years: our dedicated MDR team will guide and assist in compliance with the new legislation in all areas.